BLISTER & STRIP PACKAGING

(WITH DEFECTS & QUALITY CONTROL )

Pankaj Kusum Ramdas KhuspeM. Pharm (Pharmaceutics)

CHARACTERISTICS OF PACKAGING

PACKAGING TYPES

PACKAGING TYPES

PACKAGING TYPES

TYPES OF PACKAGING

Blister packaging

Strip packaging

BLISTER PACKING COMPONENTThe four basic components of pharmaceutical

blister packages are;1. The forming film (Forming films account

for approximately 80–85% of the blister package)

2. The lidding material (lidding materials make up 15–20% of the total weight of the package.)

3. Heat seal coating 4. And the printing ink

USES OF BLISTER PACKAGING IN PHARMACEUTICAL INDUSTRY

1. Provide barrier protection for shelf life requirements and degree of tamper resistance.

2. Useful for patients.4. The drugs fully protected against adverse external

conditions. 5. Easy handle and storage.6. Protection from Moisture, Gas, Light &

Temperature7. Compliance – Regulatory & Patient

ADVANTAGES OF BLISTER PACKAGING

1. Prevention of broken glass bottles2. Reduced costs and higher packaging

speeds relative to other packaging materials.

3. Blister packaging helps retain product integrity because drugs that are prepackaged in blisters are shielded from adverse conditions.

4. Furthermore, opportunities for product contamination are minimal.

5. and each dose is identified by product name, lot number, and expiration date.

ADVANTAGES OF BLISTER PACKAGING

4. Blister packaging protects pharmaceuticals in the home better than bottles do.

5. Tamper evidence is another strength of blister packaging.

STRIP PACKAGING

INTRODUCTION

MATERIAL USED

DEFECTS AND

QUALITY CONTROL IN

BLISTER PACKAGING

Pankaj Kusum Ramdas KhuspeM. Pharm (Pharmaceutics)

CLASSIFICATION OF DEFECTS IN PACKAGING

1. Class A – Critical Defects2. Class B –Major Defects3. Class C –Minor Defects

CLASS A – CRITICAL DEFECTS

Critical defects are those which prevents a package from performing its intended function of protecting its contents. It also prevents from compliance of regulatory region that causes hazards in handling or disposal.

The acceptance quality level (AQL) for critical defects is 0 i.e. container or closure has to be rejected.

Cracked or chipped glass bottle Fracture in can Puncture in pouch Missing liner in closure

CLASS B – MAJOR DEFECTSMajor defects are those which cause borderline functionality in

a package. It reduces the identity of a packaging system by virtue of graphic defects.

The acceptance quality level (AQL) for major defects is 0.15 to 1.50.

Missing colour in lithography Cartons out of square Heat seal is too narrow Blotted printing in aluminum foils

CLASS C – MINOR DEFECTSMinor defects are those which impair the appearance but not the

function of package. These defects are also called as appearance defects.The acceptance quality level (AQL) for minor defects is 4.0 to

6.5.

Stones or air bubbles in glass bottles Small dents & scratches on can Cap colour is off standard Printing out of register Scratches on the aluminum foil Uneven outer surface of bottle

DEFECTS IN SOLID DOSAGE FORMS Solid dosage forms like tablet, capsule, pills are generally packed in

blister packs & strip packs. The common defects observed in this class are as

follows :-

o Seal defects

o Pin holes

o Blocking

o Embedded foreign matter

o Scratches on lamination

o Mould lines

MAIN CAUSES OF DEFECTS

Joint or material failures are potential problems.

If the packaging material is not sufficiently strong, then failure can occur as

a collapse, rupture, tear or crack.

Closures are also responsible for packaging defects.

Sometimes packaging machines are not set correctly, thereby producing

thousands of out of specifications packages.

Acceptance Criteria For Defects

Blister Packaging

Aluminium Foil

Quality Control for Packaging

THANK YOU…